Summary: Genmab announces the initiation of a Phase III study of HuMax-EGFr to
treat head and neck cancer in cooperation with DAHANCA.
Copenhagen, Denmark; September 13, 2007 - Genmab A/S (OMX: GEN) announced today
the initiation of a Phase III study of HuMax-EGFr(TM) (zalutumumab) to treat
head and neck cancer in cooperation with the Danish Head and Neck Cancer Group
(DAHANCA). The study will include approximately 600 previously untreated head
and neck cancer patients to assess whether concomitant therapy with HuMax-EGFr
can improve the efficacy of primary curative radiotherapy.
“We are excited for DAHANCA to begin the largest HuMax-EGFr trial to date,” said
Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “We hope that
HuMax-EGFr provides additional benefit to head and neck cancer patients
receiving radiotherapy.”
About the trial
Patients in the study will be randomized to treatment with radiotherapy or
HuMax-EGFr plus radiotherapy. All patients will receive treatment with
accelerated radiotherapy plus nimorazole and may also receive cisplatin
chemotherapy. Patients receiving HuMax-EGFr will receive six weekly doses of 8
mg/kg of HuMax-EGFr. Patients will be followed for at least 5 years and will be
clinically evaluated at months 2, 5, 8 and 12 after completion of treatment.
Evaluations will continue every 4 months in the second year and every 6 months
the third and fourth year and once a year thereafter.
The objective of the study is to determine the efficacy of HuMax-EGFr in
combination with radiotherapy in treating patients with squamous cell carcinoma
of the head and neck. The primary endpoint is loco-regional control and
secondary endpoints are overall survival, disease free survival and acute and
late side effects.
About cancers of the head and neck
Head and neck cancers may affect the mouth, nasal cavities, sinuses, larynx and
pharynx. Most are squamous carcinomas but others include lymphoepithelioma and
lymphoma. Head and neck cancers account for 3 % of all cancers in the U.S.,
with 40,000-60,000 cases diagnosed and 12,000 deaths annually. Worldwide
incidence is about half a million with nearly 250,000 deaths.
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing
fully human antibody therapeutics for unmet medical needs. Using unique,
cutting-edge antibody technology, Genmab's world class discovery and development
teams have created and developed an extensive pipeline of products for potential
treatment of a variety of diseases including cancer and autoimmune disorders.
As Genmab advances towards a commercial future, we remain committed to our
primary goal of improving the lives of patients who are in urgent need of new
treatment options. For more information on Genmab's products and technology,
visit www.genmab.com.
This press release contains forward looking statements. The words “believe”,
“expect”, “anticipate”, “intend” and “plan” and similar expressions identify
forward looking statements. Actual results or performance may differ materially
from any future results or performance expressed or implied by such statements.
The important factors that could cause our actual results or performance to
differ materially include, among others, risks associated with product discovery
and development, uncertainties related to the outcome and conduct of clinical
trials including unforeseen safety issues, uncertainties related to product
manufacturing, the lack of market acceptance of our products, our inability to
manage growth, the competitive environment in relation to our business area and
markets, our inability to attract and retain suitably qualified personnel, the
unenforceability or lack of protection of our patents and proprietary rights,
our relationships with affiliated entities, changes and developments in
technology which may render our products obsolete, and other factors. Genmab is
not under an obligation to up-date statements regarding the future following the
publication of this release; nor to confirm such statements in relation to
actual results, unless this is required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD4(R); HuMax-CD20(R);
HuMax-EGFr(TM); HuMax-Inflam(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM);
HuMax-ZP3(TM); and UniBody(TM) are all trademarks of Genmab A/S.
Contact: Helle Husted, Sr. Director, Investor Relations, T: +45 33 44 77 30, M:
+45 25 27 47 13, E: hth@genmab.com
Stock Exchange Release no. 38/2007
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